Journal of Clinical Oncology, Vol 4, 1772-1779, Copyright © 1986 by American Society of Clinical Oncology
A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer
RD Gelber and A Goldhirsch
Between 1978 and 1981, 463 evaluable postmenopausal patients 65 years of
age or younger with operable breast cancer and metastases in axillary lymph
nodes were entered in Ludwig Breast Cancer Study III (Ludwig III) and
randomly allocated to receive chemoendocrine therapy with cyclophosphamide,
methotrexate, 5-fluorouracil, low-dose continuous prednisone, and tamoxifen
(CMFp + T) for 12 monthly cycles, or endocrine therapy alone with
prednisone and tamoxifen (p + T) for 1 year, or no adjuvant treatment after
mastectomy (observation). At 60 months' median follow-up, the 5-year
disease-free survival (DFS) rates were 59% for CMFp + T, 41% for p + T, and
31% for observation (P less than .0001), and the 5-year overall survival
(OS) rates were 71% for CMFp + T, 64% for p + T, and 59% for observation (P
= .16; CMFp + T v observation, P = .07). A new quality of life-oriented
endpoint was defined to assist in the selection of therapeutic approach
after surgery for postmenopausal patients: the time without symptoms of
disease and subjective toxic effects of treatment (TWiST). Despite the
larger initial discount due to subjective toxicity with chemoendocrine
therapy, by 5 years postmastectomy the net difference in average TWiST for
treated patients compared with the observation group was positive and
approximately equal for both adjuvant treatment programs. Adjuvant
chemoendocrine therapy for postmenopausal women appears to be justified due
to an emerging OS advantage and increasing TWiST gained for the treated
patients.
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